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Effectiveness of the HuCare Quality Improvement Strategy on health-related quality of life in patients with cancer: study protocol of a stepped-wedge cluster randomised controlled trial (HuCare2 study).

ABSTRACT: INTRODUCTION:Our group previously demonstrated the feasibility of the HuCare Quality Improvement Strategy (HQIS), aimed at integrating into practice six psychosocial interventions recommended by international guidelines. This trial will assess whether the introduction of the strategy in oncology wards improves patient's health-related quality of life (HRQoL). METHODS AND ANALYSIS:Multicentre, incomplete stepped-wedge cluster randomised controlled trial, conducted in three clusters of five centres each, in three equally spaced time epochs. The study also includes an initial epoch when none of the centres are exposed to the intervention, and a final epoch when all centres will have implemented the strategy. The intervention is applied at a cluster level, and assessed at an individual level with cross-sectional model. A total of 720 patients who received a cancer diagnosis in the previous 2 months and about to start medical treatment will be enrolled. The primary aim is to evaluate the effectiveness of the HQIS versus standard care in terms of improvement of at least one of two domains (emotional and social functions) of HRQoL using the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items) questionnaire, at baseline and at 3 months. This outcome was chosen because patients with cancer generally exhibit low HRQoL, particularly at certain stages of care, and because it allows to assess the strategy's impact as perceived by patients themselves. The HQIS comprises three phases: (1) clinician training-to improve communication-relational skills and instruct on the project; (2) centre support-four on-site visits by experts of the project team, aimed to boost motivation, help with context analysis and identification of solutions; (3) implementation of Evidence-Based Medicine (EBM) recommendations at the centre. ETHICS AND DISSEMINATION:Ethics committee review approval has been obtained from the Ethics Committee of Parma. Results will be disseminated at conferences, and in peer-reviewed and professional journals intended for policymakers and managers. TRIAL REGISTRATION NUMBER:NCT03008993; Pre-results.

SUBMITTER: Caminiti C

PROVIDER: S-EPMC5640062 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Effectiveness of the HuCare Quality Improvement Strategy on health-related quality of life in patients with cancer: study protocol of a stepped-wedge cluster randomised controlled trial (HuCare2 study).

Caminiti Caterina C Iezzi Elisa E Passalacqua Rodolfo R

BMJ open 20171006 10

<h4>Introduction</h4>Our group previously demonstrated the feasibility of the HuCare Quality Improvement Strategy (HQIS), aimed at integrating into practice six psychosocial interventions recommended by international guidelines. This trial will assess whether the introduction of the strategy in oncology wards improves patient's health-related quality of life (HRQoL).<h4>Methods and analysis</h4>Multicentre, incomplete stepped-wedge cluster randomised controlled trial, conducted in three clusters ...[more]

PMID: 28988170

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Project description:ImportanceMany patients with cancer who would benefit from psychosocial care do not receive it. Implementation strategies may favor the integration of psychosocial care into practice and improve patient outcomes.ObjectiveTo evaluate the effectiveness of the Humanization in Cancer Care (HuCare) Quality Improvement Strategy vs standard care as improvement of at least 1 of 2 domains (emotional or social function) of patient health-related quality of life at baseline and 3 months. A key secondary aim included investigation of the long-term effect.Design, setting, and participantsHuCare2 was a multicenter, incomplete, stepped-wedge cluster randomized clinical trial, conducted from May 30, 2016, to August 28, 2019, in three 5-center clusters of cancer centers representative of hospital size and geographic location in Italy. The study was divided into 5 equally spaced epochs. Implementation sequence was defined by a blinded statistician; the nature of the intervention precluded blinding for clinical staff. Participants included consecutive adult outpatients with newly diagnosed cancer of any type and stage starting medical cancer treatment.InterventionsThe HuCare Quality Improvement Strategy comprised (1) clinician communication training, (2) on-site visits for context analysis and problem-solving, and (3) implementation of 6 evidence-based recommendations.Main outcomes and measuresThe primary outcome was the difference between the means of changes of individual scores in emotional or social functions of health-related quality of life detected at baseline and 3-month follow-up (within each group) and during the postintervention epoch compared with control periods (between groups). Long-term effect of the intervention (at 12 months) was assessed as a secondary outcome. Intention-to-treat analysis was used.ResultsA total of 762 patients (475 [62.3%] women) were enrolled (400 HuCare Quality Improvement Strategy and 362 usual care); mean (SD) age was 61.4 (13.1) years. The HuCare Quality Improvement Strategy significantly improved emotional function during treatment (odds ratio [OR], 1.13; 95% CI, 1.04-1.22; P = .008) but not social function (OR, 0.99; 95% CI, 0.89-1.09; P = .80). Effect on emotional function persisted at 12 months (OR, 1.05; 95% CI, 1.00-1.10; P = .04).Conclusions and relevanceIn this trial, the HuCare Quality Improvement Strategy significantly improved the emotional function aspect of health-related quality of life during cancer treatment and at 12 months, indicating a change in clinician behavior and in ward organization. These findings support the need for strategies to introduce psychosocial care; however, more research is needed on factors that may maximize the effects.Trial registrationClinicalTrials.gov Identifier: NCT03008993.

Project description:IntroductionThe acute respiratory distress syndrome (ARDS) is a highly relevant entity in critical care with mortality rates of 40%. Despite extensive scientific efforts, outcome-relevant therapeutic measures are still insufficiently practised at the bedside. Thus, there is a clear need to adhere to early diagnosis and sufficient therapy in ARDS, assuring lower mortality and multiple organ failure.Methods and analysisIn this quality improvement strategy (QIS), a decision support system as a mobile application (ASIC app), which uses available clinical real-time data, is implemented to support physicians in timely diagnosis and improvement of adherence to established guidelines in the treatment of ARDS. ASIC is conducted on 31 intensive care units (ICUs) at 8 German university hospitals. It is designed as a multicentre stepped-wedge cluster randomised QIS. ICUs are combined into 12 clusters which are randomised in 12 steps. After preparation (18 months) and a control phase of 8 months for all clusters, the first cluster enters a roll-in phase (3 months) that is followed by the actual QIS phase. The remaining clusters follow in month wise steps. The coprimary key performance indicators (KPIs) consist of the ARDS diagnostic rate and guideline adherence regarding lung-protective ventilation. Secondary KPIs include the prevalence of organ dysfunction within 28 days after diagnosis or ICU discharge, the treatment duration on ICU and the hospital mortality. Furthermore, the user acceptance and usability of new technologies in medicine are examined. To show improvements in healthcare of patients with ARDS, differences in primary and secondary KPIs between control phase and QIS will be tested.Ethics and disseminationEthical approval was obtained from the independent Ethics Committee (EC) at the RWTH Aachen Faculty of Medicine (local EC reference number: EK 102/19) and the respective data protection officer in March 2019. The results of the ASIC QIS will be presented at conferences and published in peer-reviewed journals.Trial registration numberDRKS00014330.

Project description:IntroductionAntimicrobial treatment of asymptomatic bacteriuria (ASB) is one of the most common unnecessary uses of antimicrobials. Earlier studies have shown that the prevalence of this inappropriate treatment ranges from 45% to 83%. Multifaceted interventions based on international guidelines and antimicrobial stewardship can decrease overtreatment of ASB. We have designed a study protocol with the main objective of reducing overtreatment of ASB by 50% through use of a deimplementation strategy.Methods and analysisWe will use a stepped-wedge cluster randomised design, comparing outcomes before and after introduction of our intervention in the emergency department (ED) of five hospitals (clusters) in the Netherlands. All patients (≥18 years old) who have a urine test performed in the ED will be screened for eligibility. The deimplementation strategy consists of a combination of interventions, including education, audit and feedback. The primary endpoint is overtreatment of ASB in patients without risk factors (eg, pregnancy, planned invasive urological procedures and neutropenia). Secondary endpoints are the duration of antimicrobial treatment for ASB, the number of urine cultures and urinalysis per 1000 patients, and overtreatment of positive urinalysis in asymptomatic patients.Ethics and disseminationEthical approval was obtained from the medical ethics research committee of the Academic Medical Centre (Amsterdam, the Netherlands) with a waiver for informed consent. Local feasibility was obtained by the local institutional review boards of all participating hospitals. Our study aims to reduce inappropriate screening and treatment of ASB in EDs, improve healthcare quality, lower the increase in antimicrobial resistance and save costs. If proven (cost)-effective, this study provides a well-suited strategy for a nationwide approach to reduce overtreatment of ASB. Relevant results of our study will be disseminated through publications in peer-reviewed journals and presentations at relevant (scientific) conferences.Trial registration numberNL8242; Pre-results.

Project description:PurposeSupporting the provision of intensive care medicine through telehealth potentially improves process quality. This may improve patient recovery and long-term outcomes. We investigated the effectiveness of a multifaceted telemedical programme on the adherence to German quality indicators (QIs) in a regional network of intensive care units (ICUs) in Germany.MethodsWe conducted an investigator-initiated, large-scale, open-label, stepped-wedge cluster randomised controlled trial enrolling adult ICU patients with an expected ICU stay of ≥ 24 h. Twelve ICU clusters in Berlin and Brandenburg were randomly assigned to three sequence groups to transition from control (standard care) to the intervention condition (telemedicine). The quality improvement intervention consisted of daily telemedical rounds guided by eight German acute ICU care QIs and expert consultations. Co-primary effectiveness outcomes were patient-specific daily adherence (fulfilled yes/no) to QIs, assessed by a central end point adjudication committee. Analyses used mixed-effects logistic modelling adjusted for time. This study is completed and registered with ClinicalTrials.gov (NCT03671447).ResultsBetween September 4, 2018, and March 31, 2020, 1463 patients (414 treated on control, 1049 on intervention condition) were enrolled at ten clusters, resulting in 14,783 evaluated days. Two randomised clusters recruited no patients (one withdrew informed consent; one dropped out). The intervention, as implemented, significantly increased QI performance for "sedation, analgesia and delirium" (adjusted odds ratio (99.375% confidence interval [CI]) 5.328, 3.395-8.358), "ventilation" (OR 2.248, 1.198-4.217), "weaning from ventilation" (OR 9.049, 2.707-30.247), "infection management" (OR 4.397, 1.482-13.037), "enteral nutrition" (OR 1.579, 1.032-2.416), "patient and family communication" (OR 6.787, 3.976-11.589), and "early mobilisation" (OR 3.161, 2.160-4.624). No evidence for a difference in adherence to "daily multi-professional and interdisciplinary clinical visits" between both conditions was found (OR 1.606, 0.780-3.309). Temporal trends related and unrelated to the intervention were detected. 149 patients died during their index ICU stay (45 treated on control, 104 on intervention condition).ConclusionA telemedical quality improvement program increased adherence to seven evidence-based German performance indicators in acute ICU care. These results need further confirmation in a broader setting of regional, non-academic community hospitals and other healthcare systems.

Project description:ObjectivesFrontline insights into care delivery correlate with patients' clinical outcomes. These outcomes might be improved through near-real time identification and mitigation of staff concerns. We evaluated the effects of a prospective frontline surveillance system on patient and team outcomes.DesignProspective, stepped wedge, non-randomised, cluster controlled trial; prespecified per protocol analysis for high-fidelity intervention delivery.ParticipantsSeven interdisciplinary medical ward teams from two hospitals in the UK.InterventionProspective clinical team surveillance (PCTS): structured daily interdisciplinary briefings to capture staff concerns, with organisational facilitation and feedback.Main measuresThe primary outcome was excess length of stay (eLOS): an admission more than 24 hours above the local average for comparable patients. Secondary outcomes included safety and teamwork climates, and incident reporting. Mixed-effects models adjusted for time effects, age, comorbidity, palliation status and ward admissions. Safety and teamwork climates were measured with the Safety Attitudes Questionnaire. High-fidelity PCTS delivery comprised high engagement and high briefing frequency.ResultsImplementation fidelity was variable, both in briefing frequency (median 80% working days/month, IQR 65%-90%) and engagement (median 70 issues/ward/month, IQR 34-113). 1714/6518 (26.3%) intervention admissions had eLOS versus 1279/4927 (26.0%) control admissions, an absolute risk increase of 0.3%. PCTS increased eLOS in the adjusted intention-to-treat model (OR 1.32, 95% CI 1.10 to 1.58, p=0.003). Conversely, high-fidelity PCTS reduced eLOS (OR 0.79, 95% CI 0.67 to 0.94, p=0.006). High-fidelity PCTS also increased total, high-yield and non-nurse incident reports (incidence rate ratios 1.28-1.79, all p<0.002). Sustained PCTS significantly improved safety and teamwork climates over time.ConclusionsThis study highlighted the potential benefits and pitfalls of ward-level interdisciplinary interventions. While these interventions can improve care delivery in complex, fluid environments, the manner of their implementation is paramount. Suboptimal implementation may have an unexpectedly negative impact on performance.Trial registration numberISRCTN 34806867 (http://www.isrctn.com/ISRCTN34806867).

Project description:BACKGROUND:Cluster randomised trials with unequal sized clusters often have lower precision than with clusters of equal size. To allow for this, sample sizes are inflated by a modified version of the design effect for clustering. These inflation factors are valid under the assumption that randomisation is stratified by cluster size. We investigate the impact of unequal cluster size when that constraint is relaxed, with particular focus on the stepped-wedge cluster randomised trial, where this is more difficult to achieve. METHODS:Assuming a multi-level mixed effect model with exchangeable correlation structure for a cross-sectional design, we use simulation methods to compare the precision for a trial with clusters of unequal size to a trial with clusters of equal size (relative efficiency). For a range of scenarios we illustrate the impact of various design features (the cluster-mean correlation - a function of the intracluster correlation and the cluster size, the number of clusters, number of randomisation sequences) on the average and distribution of the relative efficiency. RESULTS:Simulations confirm that the average reduction in precision, due to varying cluster sizes, is smaller in a stepped-wedge trial compared to the parallel trial. However, the variance of the distribution of the relative efficiency is large; and is larger under the stepped-wedge design compared to the parallel design. This can result in large variations in actual power, depending on the allocation of clusters to sequences. Designs with larger variations in cluster sizes, smaller number of clusters and studies with smaller cluster-mean correlations (smaller cluster sizes or smaller intra-cluster correlation) are particularly at risk. CONCLUSION:The actual realised power in a stepped-wedge trial might be substantially higher or lower than that estimated. This is particularly important when there are a small number of clusters or the variability in cluster sizes is large. Constraining the randomisation on cluster size, where feasible, might mitigate this effect.

Project description:BackgroundDespite many efforts, long wait times and overcrowding in emergency departments (EDs) have remained a significant health service issue in Canada. For several years, Canada has had one of the longest wait times among the Organisation for Economic Co-operation and Development countries. From a patient's perspective, this challenge has been described as "patients wait in pain or discomfort for hours before being seen at EDs." To overcome the challenge of increased wait times, we developed an innovative ED management platform called SurgeCon that was designed based on continuous quality improvement principles to maintain patient flow and mitigate the impact of patient surge on ED efficiency. The SurgeCon quality improvement intervention includes a protocol-driven software platform, restructures ED organization and workflow, and aims to establish a more patient-centric environment. We piloted SurgeCon at an ED in Carbonear, Newfoundland and Labrador, and found that there was a 32% reduction in ED wait times.ObjectiveThe primary objective of this trial is to determine the effects of SurgeCon on ED performance by assessing its impact on length of stay, the time to a physician's initial assessment, and the number of patients leaving the ED without being seen by a physician. The secondary objectives of this study are to evaluate SurgeCon's effects on patient satisfaction and patient-reported experiences with ED wait times and its ability to create better-value care by reducing the per-patient cost of delivering ED services.MethodsThe implementation of the intervention will be assessed using a comparative effectiveness-implementation hybrid design. This type of hybrid design is known to shorten the amount of time associated with transitioning interventions from being the focus of research to being used for practice and health care services. All EDs with 24/7 on-site physician support (category A hospitals) will be enrolled in a 31-month, pragmatic, stepped wedge cluster randomized trial. All clusters (hospitals) will start with a baseline period of usual care and will be randomized to determine the order and timing of transitioning to intervention care until all hospitals are using the intervention to manage and operationalize their EDs.ResultsData collection for this study is continuing. As of February 2022, a total of 570 randomly selected patients have participated in telephone interviews concerning patient-reported experiences and patient satisfaction with ED wait times. The first of the 4 EDs was randomly selected, and it is currently using SurgeCon's eHealth platform and applying efficiency principles that have been learned through training since September 2021. The second randomly selected site will begin intervention implementation in winter 2022.ConclusionsBy assessing the impact of SurgeCon on ED services, we hope to be able to improve wait times and create better-value ED care in this health care context.Trial registrationClinicalTrials.gov NCT04789902; https://clinicaltrials.gov/ct2/show/NCT04789902.International registered report identifier (irrid)DERR1-10.2196/30454.

Project description:ImportanceInfections and complications following cesarean delivery are a significant source of maternal mortality in Ethiopia.ObjectiveTo study the effectiveness of a program to strengthen compliance with perioperative standards and reduce postoperative complications following cesarean delivery.Design, setting, and participantsThis stepped-wedge cluster randomized clinical trial included patients undergoing cesarean delivery from August 24, 2021, to January 31, 2023, at 9 hospitals organized into 5 clusters in Ethiopia.InterventionClean Cut, a multimodal surgical quality improvement program that includes process-mapping 6 perioperative standards and creating site-specific, systems-level improvements. The control period was the period before implementation of the intervention.Main outcomes and measuresThe primary end point was surgical site infection rate, and secondary end points were maternal mortality and perinatal mortality and a composite outcome of infections and both mortality outcomes. All were assessed at 30 days postoperatively in the intervention and control groups, adjusting for clustering and demographics. Compliance with standards and the relationship between compliance and outcomes were also compared between the 2 arms.ResultsAmong 9755 women undergoing cesarean delivery, 5099 deliveries (52.3%) occurred during the control period (2722 emergency cases [53.4%]) and 4656 (47.7%) during the intervention period (2346 emergency cases [50.4%]). Mean (SD) patient age was 27.04 (0.05) years. Thirty-day follow-up was completed for 5153 patients (52.8%). No significant reduction in infection rates was detected after the intervention (OR, 0.84; 95% CI, 0.55-1.27; P = .40). Intraoperative infection prevention standards improved significantly in the intervention arm vs control arm for compliance with at least 5 of the 6 standards (odds ratio [OR], 2.95; 95% CI, 2.40-3.62; P < .001). Regardless of trial arm, high compliance was associated with reduced odds of maternal (OR, 0.32; 95% CI, 0.11-0.93; P = .04) and perinatal (OR, 0.64; 95% CI, 0.47-0.89; P = .008) mortality.Conclusions and relevanceIn this stepped-wedge cluster randomized clinical trial of patients undergoing cesarean delivery, no significant reductions in surgical site infections were observed. However, compliance with perioperative standards improved following the intervention.Trial registrationClinicalTrials.gov Identifier: NCT04812522; Pan-African Clinical Trials Registry Identifier: PACTR202108717887402.

Dataset Information

Effectiveness of the HuCare Quality Improvement Strategy on health-related quality of life in patients with cancer: study protocol of a stepped-wedge cluster randomised controlled trial (HuCare2 study).

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Effectiveness of the HuCare Quality Improvement Strategy on health-related quality of life in patients with cancer: study protocol of a stepped-wedge cluster randomised controlled trial (HuCare2 study).

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